Replies to post #461028 on Anavex Life Sciences Corp (AVXL)

[Hosai]

Hello William, I'm sort of in agreement but I think it's a case of wondering what the minimum possible time could theoretically be versus the most likely or normal timeline.
The 7 months intention to submit before submission seems to read as more of a "minimum time before submission" rule whereas the guidelines for the submission time after rappateur selection reads more like a "maximum time before submission" rule.

"EMA recommends providing the eligibility request preferably, at the earliest, 18 months before submission of the marketing authorisation application (MAA) and, at the latest, 7 months before the MAA is filed with the EMA, at which point it could be submitted as part of the “letter of intent to submit”. For Eligibility requests submitted as part of the “letter of intent to submit”, Rapporteurs will be automatically appointed following the confirmation of the eligibility to the centralised procedure provided that the planned submission date is within 6-7 months."

As you say though I suppose it would appear the latest would be 7 months after Feb 7th so Sept 7th. However they could have submitted just after Jan 10th which would mean mid August.
As I said though I don't think it gives a minimum in regards to the rappateurs even if normally 6-7 months would be expected.
They can apply later but have to write in to request a later date if they aren't going to meet the planned date.

[Steady_T]

I don't understand what the Jan 10th submission deadline. Would you elaborate on that please?

My understanding of the process is The request for centralized marketing authorization. Letter of Intent can be submitted at the same time but is not a requirement.

The Letter of Intent (LOI) specifies an expected date for the submission of the MAA package. It must be at least 7 months post LOI submission date. Submission of the LOI starts the Rapporteurs appointment process. What has not been mentioned is that the EMA encourages meetings during the process, starting even before the LOI submission and afterwards.

On the proposed submission date the MAA package is submitted and that starts the 210 day or 150 day accelerated timeline for MAA approval if accepted. There are two possible clock stops in the regular approval process. The first one can be up to 90 days and the second one can be up to 30 days. For accelerated assessment there will be one clock stop of up to 90 days.

The Anavex PR says the CHMP declared blarcamesine eligible for centralized regulatory review. That was Dec 19 2023. The eligibility request can be submitted 18 to 7 months before the LOI. So that really doesn't set the LOI timeline start date.

The Zacks PR quoted below says that Anavex start the process in November 2023. I couldn't find anything to confirm that information but it makes sense since the CHMP eligibility process can take a few weeks to over a month depending on when CHMP meetings are scheduled and when the request was submitted to the meeting cycle.

So far Anavex has not confirmed LOI submission and it appears they won't based on my conversations with IR. My guess is the LOI was submitted with the eligibility request. If that is true then that starts the 7 month clock.

So if that is when the LOI was submitted the MAA submission date could be late June or July. Note the the LOI must set a submission date AT LEAST 7 months in the future. As I read the rules that date can be more than 7 months in the future. Given Missling's statement about submitting early as possible I would use the 7 month minimum as a target date for MAA submission.

At least seven months before submission, applicants should notify the European Medicines Agency of their intention to submit a MAA and provide the intended date of submission. This should be done by using the Pre-submission request form Pre-submission request form (Intent to submit MA), selecting as a scope of request: Centralised Procedure-Intent to submit a MAA; this should be sent by raising a ticket via EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”. The subcategory to be selected is “Pre-Submission Phase - Human”, followed by the sub-option: “Letter of Intent Request”. The appointment procedure for (Co-)Rapporteurs will be initiated 7 months prior to the Marketing Authorisation Application intended submission date (see question "What is the procedure for appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams?").

NEW YORK – December 19, 2023
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.

Zacks Equity Research for Zacks ->

Anavex Life Sciences Corp. AVXL announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) considers its pipeline candidate, oral blarcamesine, eligible for a centralized regulatory review in the EU.

This indicates that Anavex may file a single marketing application to the European Medicines Agency. The company initiated the regulatory submission of blarcamesine for the treatment of Alzheimer’s disease to the EMA in November 2023.